Statistical Programmer

3 weeks ago


Bengaluru, Karnataka, India Clario Full time

Are you seeking a meaningful and challenging SAS programming career opportunity in the pharmaceutical industry?

Our statistical programming team at Clario is growing, and with big ambitions and a clear vision for the future, now is the time to join our team.

What we offer:

  • Competitive compensation and attractive benefits
  • Engaging employee programs and a supportive work environment

Key Responsibilities:

In the Statistical Programmer role at Clario, you will create, test, and maintain SAS codes used to create CDISC compliant datasets for cardiac safety statistical analysis. You will also create and maintain procedures for the creation of ADaM datasets and help us create electronic submission packages for cardiac safety submissions.

  • Support statistical programming activities for assigned Cardiac safety studies, including the creation of dataset specifications as per study requirements
  • Participate in process improvement for SAS programming and mentoring of new employees
  • Perform any and all functions as required to meet corporate commitments and deliverables, including creating codes for statistical datasets through SAS and reviewing and creating electronic submission deliverables for sponsor submission
  • Create and maintain SAS codes for analysis datasets, including programming analysis specific flags and other specifications per the Statistical analysis plan
  • Create submission-ready datasets for cardiac safety trials (SDTM EG and ADaM ADEG) in coordination with the client, internal statistics, and data management teams while being compliant with CDISC standards
  • Maintain a working knowledge of CDISC standards and recommend changes to processes and standard specifications as needed
  • Create define.xml and dataset reviewers guide for FDA submissions with reference to the datasets created for statistical analysis
  • Assist statisticians in the preparation of Tables Listings and Figures for cardiac safety studies
  • Assist with the orientation and training of members of the statistics team, Systems Analysts, and Data Management personnel as determined by management
  • In conjunction with the entire department, recommend, develop, and implement SOPs for improved procedures within the Statistics group

Requirements:

  • BS in Computer Sciences, Engineering, Statistics, or Mathematics
  • Experience with CDISC SDTM and ADaM standards
  • Minimum of 10 years' experience in SAS products and procedures in a pharmaceutical or life sciences setting, preferably with a strong understanding of the pharmaceutical drug development process
  • Strong organization, analytical, and communication skills
  • Detail-oriented and able to work effectively in teams
  • Excellent time management skills and ability to prioritize and balance concurrent tasks and responsibilities


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